BEIJING, Dec. 11, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced today that its next-generation TRK inhibitor, zurletrectinib (ICP-723), has received approval from the China National Medical Products Administration (NMPA) for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions.
In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively.
As a next-generation TRK inhibitor, zurletrectinib demonstrated superior efficacy compared to first-generation TRK inhibitors. It delivered durable deep remissions and exhibits strong brain penetration activity with a good safety profile. Moreover, it was also shown to overcome acquired resistance to the first-generation TRK inhibitors. The once-daily, two-tablet oral dosing has brought great convenience to patients.
Yizhuo Zhang, professor at the Sun Yat-Sen University Cancer Center, said, "NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zurletrectinib has demonstrated remarkable efficacy, particularly in achieving an ORR of 100% in adolescent patients. Clinically, zurletrectinib responds faster than traditional chemotherapy, with many patients showing substantial tumor shrinkage within one or two treatment cycles, providing a critical therapeutic window for patients in critical conditions. Moreover, zurletrectinib demonstrated a long duration of response-the longest observed in our clinical practice has exceeded 36 months-offering hope of extended survival in patients with solid tumors."
Zhiguo Luo, professor at the Fudan University Shanghai Cancer Center, said, "Most patients enrolled at our center were sarcoma cases. Zurletrectinib demonstrated an outstanding ORR of 89.5% in soft tissue sarcoma patients, showcasing excellent efficacy. Its high selectivity significantly reduces off-target toxicity, ensuring good safety and enabling long-term medication without compromising quality of life. For solid tumor patients requiring prolonged treatment, zurletrectinib's advantages in efficacy and safety allow them to live longer and better."
Qiming Wang, professor at the Henan Cancer Hospital, said, "Zurletrectinib demonstrates outstanding efficacy in NTRK fusion-positive lung cancer patients, achieving an ORR of 88.9% and bringing renewed hope to lung cancer patients. At the same time, zurletrectinib also exhibits remarkable brain penetration activity, achieving an intracranial objective response rate (IC-ORR) of 100% and a 12-month intracranial duration of response (IC-DOR) of 100%, enabling strong and durable control of brain lesions. From a molecular mechanism perspective, the unique structure of zurletrectinib allows it to cross the blood-brain barrier and maintain effective therapeutic concentrations in cerebrospinal fluid, providing new treatment options for patients with brain metastases."
Libo Chen, professor at the Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University, said, "The ORR among thyroid cancer patients enrolled in the zurletrectinib study reached 100%. Patients treated at our center have remained on therapy for two years with sustained responses, demonstrating that zurletrectinib has superior efficacy compared with first-generation TRK inhibitors. Additionally, as a next-generation TRK inhibitor, zurletrectinib offers new hope for patients who are resistant to first generation agents. With outstanding efficacy and favorable tolerability, zurletrectinib can provide long-term, deep and sustained responses for patients with NTRK fusion-positive solid tumors."
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "Zurletrectinib is InnoCare's third innovative drug approved for marketing and our first solid-tumor therapy to receive approval. It is of significant clinical importance for patients with NTRK fusion-positive solid tumors. We would like to extend our special thanks to the physicians, patients, partners, and employees who participated in this clinical trial, as well as the regulatory authorities for their professional and efficient approval, enabling more solid tumor patients to receive better treatment options earlier. We believe that zurletrectinib will bring new hope to Chinese patients with solid tumors."
Zurletrectinib has been included in the "SPARK Program" by China's National Medical Products Administration (NMPA), a pilot initiative to encourage the development of pediatric anti-tumor drugs. InnoCare anticipates submitting a new drug application (NDA) for zurletrectinib to treat pediatric patients (aged 2 to 12) in the near future.
NTRK fusion genes are present in various types of tumors and have been identified in over 26 solid tumors1. It is estimated that approximately 6,500 new cases of tumors carrying NTRK fusion genes occur annually in China. These patients often have short survival periods, rapid disease progression, and high disability rates. Due to the low adoption rate of the current gold-standard detection method-next-generation sequencing (NGS)-diagnosis is often delayed, resulting in unmet clinical needs.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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1 Westphalen CB, et al. NPJ Precis Oncol. 2021 Jul 20;5(1): 69.
